Case details
Summary
Interim relief in judicial review is governed by the American Cyanamid principles, modified as appropriate for public law. The claimant must show a serious question to be tried, meaning a real prospect of success at the substantive hearing; this is a higher threshold than arguability for permission. The court then considers whether damages would be an adequate remedy and where the balance of convenience lies. Public interest includes respect for an extant public-body decision, but the strength of the claim may materially affect the balance. Public health and safety are paramount, yet evidence of a specific current risk remains relevant. Where suspension would cause serious commercial and reputational harm and no present safety risk is shown, the court may preserve the status quo pending determination, including by requiring continued certification.
Factual background
RRR Manufacturing challenged three decisions by the British Standards Institution concerning surveillance of, and proposed suspension of, its UK certification for a handheld personal defibrillator. The claim alleged illegality, procedural unfairness, irrationality and unlawful fettering of discretion. The Medicines and Healthcare Products Regulatory Agency was an interested party.
The application concerned interim relief pending determination of the judicial review. The court considered whether there was a serious question to be tried, whether damages were an adequate remedy, and where the balance of convenience lay. Permission had not yet been determined.
Held
- The application for interim relief was granted. The British Standards Institution was restrained from suspending or withdrawing the certificate pending determination of the claim, and was required to maintain certification in place, by extension or time-limited renewal if necessary.
- The court applied the principles in American Cyanamid Co v Ethicon Limited [1975] AC 396, modified for public law. RRR had to show a serious question to be tried. In judicial review, that required a real prospect of success at the substantive hearing, a higher threshold than the arguability test for permission. The defendant conceded that this merits threshold was met.
- Damages were not an adequate remedy for either party. Suspension could cause substantial commercial and reputational harm in the UK and elsewhere, potentially threatening the claimant’s entire business. Conversely, restraint would deprive BSI of its power to prevent UK operation.
- The balance of convenience favoured maintaining the status quo. Public health and safety were paramount, but there was no evidence of a current health or safety risk, direct evidence that the device was unsafe, or a reason why the product could not remain marketed while corrective action requirements were addressed. Existing certification and approval in other jurisdictions were relevant considerations.
- The court also considered the public interest in respecting a public-body decision unless set aside. That principle did not outweigh the claimant’s case and the evidence on harm and risk. The MHRA’s suggestion that it might take enforcement action merely because an injunction had been granted was not a proper basis for exercising its powers.
- The proceedings were to be expedited, while preserving proper case preparation. Permission was not decided at the hearing, which was not listed as a permission hearing.
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